Why it was recalled
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Product description
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
Lot numbers, UPCs & expiration codes
Lot # 17P0430, Exp 05/19
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0082-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 30, 2017
- FDA report date
- Nov 22, 2017
- Quantity
- 744 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0082-2018, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 78461
- Address
- 207 Kiley Dr
- Code information
- Lot # 17P0430, Exp 05/19
- Postal code
- 21801-2249
- Report date
- Nov 22, 2017
- Product type
- Drugs
- Recall number
- D-0082-2018
- Classification
- Class III
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 744 bottles
- Termination date
- Feb 12, 2020
- Reason for recall
- Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 30, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 16, 2017